Kornimate/medical-research-clean huggingface dataset:
vitamin c on acute and chronic post mastectomy pain

Conditions: Vitamin C; Post-mastectomy Pain Syndrome

Summary: this prospective randomized double-blinded controlled study will be conducted to evaluate the effect of perioperative vitamin c on acute and chronic post mastectomy pain after breast cancer surgery

there is cumulative evidence that postoperative pain is closely associated with subsequent persistent pain lasting months. the international association for the study of pain has defined chronic postsurgical pain (cpsp) as a pain that develops after surgical intervention and persists at least 2 months.

Eligibility criteria:
inclusion criteria: * female patients aged ≥ 18years, with primary unilateral breast cancer and scheduled for lumpectomy, partial or total mastectomy with or without axillary lymph node dissection or modified radical mastectomy. exclusion criteria: - (1) patients with renal stones or renal insufficiency, patients suffering from nausea and vomiting, gastroesophageal reflux or patients with chronic pain state. (2) intake of analgesic within 24 hours before surgery. (3) patients unable to comply with the study protocol for any reason. (4) contraindications to paravertebral block (pvb) such as allergy to local anesthetics, infection, or coagulopathy.
retrospective study on the role of scfa modulation in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: recent studies show that gut microbiota strongly influences multiple sclerosis. these data suggest that the microbiota could have a direct effect on ms pathogenesis, although the mechanisms through which it modulates central nervous system (cns) neuroinflammation and neurodegeneration are still poorly defined. the microbiota mediates its action principally through synthesizing specific metabolites that act as messengers in host functions, such as the modulation of the immune and nervous system, tissue repair, and stemness. the short-chain fatty acids (scfas- mainly acetate, propionate, and butyrate), produced by the fermentation of dietary fibers, are a class of microbial metabolites of primary importance for host physiology. thus, the objective is to establish a mechanistic link between gut microbiota dysbiosis, reflected by a different level of scfas and scfa-producing bacteria species, and neuroimmune alterations in ms. preliminary data show a differential metabolomic profile in urine samples of ms patients compared to healthy controls. the authors now aim at deepening previous findings by analysing also the scfas concentration in the urines, plasma and csf by gc-ms (their level turned out to be too low to be measured by nmr) and the microbiota composition by shotgun metagenomics analysis, to track changes in the abundance of scfas-producing bacteria species.


Eligibility criteria:
inclusion criteria: - volunteers that have preventively signed the informed consent to use their samples for additional studies. exclusion criteria: - none

Keywords: gut-brain axis scfa microbiota
a safety and immunogenicity trial with an adjuvanted tuberculosis (tb) subunit vaccine in purified protein derivative (ppd) positive volunteers

Conditions: Tuberculosis

Summary: the purpose of this study is to evaluate the safety profile of an adjuvanted tb subunit vaccine administered at 0 and 2 months.


Eligibility criteria:
inclusion criteria: * male and female between 18 and 55 years old * bcg group: known to be bcg-vaccinated over 2 years before, ppd positive (range 6-15 mm or any documented value between 6-15 mm on medical file in the past), with no active, chronic or past tb disease as confirmed by chest x ray, negative quantiferon-tb gold in tube test and negative 6-day lymphocyte tests. * infection group: known to be treated for latent tb, ppdpositive (equal or over 10 mm or documented equal or over 10 mm positive on medical file in the past), previously tb infected but with no active disease confirmed by chest x ray, may have received chemoprophylaxis but with no tb treatment/chemoprophylaxis within the preceding 2 years, positive quantiferon-tb gold in tube test and/or positive 6-day lymphocyte test. * healthy based on medical examination/history at the inclusion * signed informed consent * prepared to grant authorized persons access to the medical records * the volunteer is likely to comply with instructions exclusion criteria: * granulomatous disease (by chest x-ray) * vaccinated with live vaccine 3 months before first vaccination * administration of immune modulating drugs (steroids, immunosuppressive drugs or immunoglobulins) 3 months before the first vaccination * hbv, hcv or hiv sero-positive * participation in other clinical trials * known hypersensitivity to any of the vaccine components * laboratory parameters outside of normal range judged by pi to be clinically relevant * pregnant women/planned pregnancy and/or breastfeeding within the trial period

Keywords: tuberculosis vaccine ag85b esat-6 ic31
outcomes for lumbar decompressions with use of liposomal bupivicaine

Conditions: Lumbar Spinal Stenosis

Summary: evaluate the benefit of using liposomal bupivicaine in lumbar laminectomies in terms of length of stay, iv narcotic use, 30-day narcotic use, visual analog score (vas) and 30-day readmissions

recent evidence suggests the use of liposomal bupivicaine (lb) in lumbar spine surgery shortens length of hospital stay and overall post-operative narcotic use. studies have shown its utility in single level microdiscectomies and lumbar fusions, but there have been no publications regarding lumbar laminectomies and associated outcomes with lb. the investigators' hypothesis is that lb will significantly shorten inpatient stays as well as overall narcotic usage in single, double or multi-level lumbar laminectomies.

Eligibility criteria:
inclusion criteria: 1. male or female 2. adult (≥18 yo) 3. lumbar stenosis exclusion criteria: 1. co-morbidities precluding surgery 2. ≤18 yo 3. pregnant 4. breastfeeding 5. need for instrumented fusion 6. prisoners 7. intra-operative csf leak (identified by gush of csf) 8. daily pre-operative opioid use of \> 25 morphine eq/day 9. previous lumbar surgery at indicated level
to study generic estradiol 10 mcg vaginal tablets in the treatment of vulvar and vaginal atrophy in post menopausal women.

Conditions: Vulvar and Vaginal Atrophy

Summary: this is a randomized, parallel-group, placebo- controlled, multicenter study to evaluate the therapeutic equivalence and safety of estradiol vaginal tablets 10 mcg and vagifem® (estradiol vaginal tablets) 10 mcg (novo nordisk inc.) in female subjects with moderate to severe symptoms of vulvar and vaginal atrophy associated with menopause.


Eligibility criteria:
inclusion criteria: 1. female postmenopausal subjects aged \>30 to \<75 years 2. at least 1 subject assessed moderate to severe symptom of vulvar and vaginal atrophy among the following that is identified as being the most bothersome to her * vaginal dryness * vaginal and/or vulvar irritation/ itching * dysuria * vaginal pain associated with sexual activity * presence of vaginal bleeding associated with sexual activity 3. have \ 5.0 at visit 1 4. systolic blood pressure \<150mm hg and diastolic blood pressure \<90mm hg at visit 1 exclusion criteria: 1. known hypersensitivity to estradiol vaginal tablet 2. screening mammogram or clinical breast examination results indicating any suspicion of breast malignancy. 3. history of undiagnosed vaginal bleeding. 4. history of significant risk factors for endometrial cancer 5. for women with an intact uterus, screening vaginal ultrasonography showing endometrial thickness of ≥ 4 mm.
vytorin on carotid intima-media thickness and overall rigidity

Conditions: Cardiovascular Diseases

Summary: comparison of the effect on the progression of the carotid intima-media interphase thickness (gim), arterial rigidity according to the measurement of the pulse wave speed and direct measurement of the carotid and aortic rigidities and an inflammation marker (pcr) in patients with established cardiovascular disease (myocardial infarct, atherosclerotic coronary disease), diabetes mellitus type 2 or equivalent risk of coronary disease and a low density lipoprotein level \> 100 mg/dl, treated with simvastatin, pravastatin or the combination of simvastatin-ezetimibe during a period of at least one year.


Eligibility criteria:
inclusion criteria: * ldl-c levels \>100 mg/dl * patients who have signed the consent * patients of ages between 30 and 75 years old * patients of both genders * patients with established cardiovascular disease, diabetes with or without established cardiovascular disease * patients without previous treatment with ezetimibe
assessment of pain in newborns and older infants (infant pain assessment study =

Conditions: Pain, Acute

Summary: pain assessments in non-verbal, critically ill infants represent an important clinical challenge. older children or adults can easily express their pain, but infants lack that capability. they frequently experience repetitive acute pain during routine icu care, but their analgesic management flounders on the horns of a dilemma: (a) failure to treat infant pain leads to immediate clinical instability and potentially long-term physical, behavioral, and cognitive sequelae, vs. (b) strong analgesics may increase risks for medical complications and/or impaired brain growth. bedside nurses currently assess pain using pain scores, before taking action to ameliorate pain. pain scores increase nursing workload and provide subjective assessments, rather than objective data for evaluating infant pain. consequently, infants exposed to skin-breaking procedures, surgery, or other painful conditions often receive variable and inconsistent pain management in the icu. the investigators aim to develop a multimodal pain assessment system, using sensor fusion and novel machine learning algorithms to provide an objective measure of pain that is context-dependent and rater-independent. this will enhance the quality of pain management in icus and allow continuous pain monitoring in real-time.


Eligibility criteria:
inclusion criteria: * 1. all infants less than 6 months of corrected chronological age. 2. infants admitted to the participating icus at lpch (nicu, picu, cvicu). 3. require an acute painful procedure for routine clinical care. exclusion criteria: 1. newborns with birth trauma, intrapartum asphyxia (5-minute apgar score \<4 or cord ph \< 7.01), fetal growth restriction (birth weight \< 5th percentile for gestation), congenital anomalies or metabolic disorders, or any kind of brain injury. 2. newborns born to mothers with a history of heavy smoking or drug abuse (alcohol, cocaine, ketamine, heroin/other opiates) or psychiatric drugs used during this pregnancy. 3. newborns and infants requiring positive pressure ventilation using a face mask (bipap) or endotracheal tube (conventional or high-frequency ventilators). 4. newborns and infants receiving continuous infusions of opioid drugs (morphine, fentanyl, others) and nerve blocks or neuraxial analgesia affecting the site of the invasive procedure during the 24 hours prior to study entry. (note: infants receiving intermittent opioids or non-opioid analgesics (acetaminophen, ibuprofen, ketorolac, others) will not be excluded). 5. newborns and infants with facial anomalies, injuries or other pathologies affecting the facial area.

Keywords: infant-newborn infant-premature pain acute pain
the impact of the use of the maurisse application in people suffering from an addiction.

Conditions: Substance Related Disorder; Personality Disorders

Summary: substance use disorders (sud) are associated with cognitive schemas that lead to care attrition and mistrust towards care. considering this, establishing a strong, trustful relationship between the patient and the healthcare team is important to promote patient engagement within sud management. however, it requires an important availability of the healthcare team, allowing for frequent interactions at all times, including at night and during days off. we postulated that a mobile application called maurisse, which aims to help the caregivers maintaining a link with the patient in order to facilitate trust in the relationship, could foster patient engagement as well as the therapeutic alliance. this research aims to compare the effect of the application maurisse on the therapeutic alliance in a population of patients treated for a disorder related to substance use at the toulouse university hospital.

substance use disorders (sud) are frequently associated with other mental disorders, especially borderline personality disorder, thus defining co-occurring substance use and mental disorders with borderline and anti-social personality disorders that is often associated with cognitive schemas leading to care attrition and mistrust towards care. the goal of the care intervention within substance use disorders management is therefore to help the patient reduce the use of dysfunctional coping strategies involving substance use. indeed, the establishment of a trustful relation between the patient and the care team leads the patient into building a secure attachment towards care that could secondly be generalized in other situations. we designed an application called maurisse, which aims to help the caregivers maintaining a link with the patient in order to facilitate a more secure attachment, thus enabling trust in the relationship as well as fostering patient engagement in the care.

Eligibility criteria:
inclusion criteria: * patient over 18 years old, * starting specialized treatment for addiction (addiction to substance and behavioral addiction too as money games addiction). * suffering from any type of addiction, with an active addiction requiring weekly monitoring of substance use. * possessing a smartphone or having access to a smartphone and having access to an internet connection. * able to read and understand french. * affiliated or beneficiary of a social security scheme. * free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research). exclusion criteria: * patient with cognitive or psychiatric disorders that may affect their ability to consent. * participation in another protocol involving a modification of the treatment for addiction. * known or suspected pregnancy. * person under legal protection.

Keywords: ehealth mhealth application substance use disorders personality disorders care observance therapeutic alliance
influence of a residential rehabilitation program on body composition in patients with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the aim is to evaluate the impact of a 3-week lasting residential rehabilitation program for patients with cystic fibrosis on their nutritional status measured as bmi and body composition and pulmonary function.

cystic fibrosis patients following a residential rehabilitation program consisting of dietary adaptation, physical therapy for airway drainage and supervised inhalation therapy and physical activity for at least 3 weeks are asked to participate. weight, height, body composition and pulmonary function will be measured at start and end of the program. dietary intake during the program is calculated based on a 2 day weighed intake diary and physical activity will be measured with the "sensewear pro 3" armband.

Eligibility criteria:
inclusion criteria: * cystic fibrosis * stay at the rehabilitation center for at least 3 consecutive weeks exclusion criteria: * steroid use * absence from the program for more than 2 consecutive days

Keywords: body composition rehabilitation
effect of oral curcumin supplementation in dry age-related macular degeneration (amd) patients

Conditions: Age Related Macular Degeneration

Summary: nutrition plays an important role in preventing progression of dry age related macular degeneration (amd), a disease of aging that leads to drusen deposits in the macula causing significant decrease in vision. drusen contains amyloid protein which is inhibited by curcumin, a natural plant based antioxidant. oral longvida curcumin has been shown to accumulate in the retina of human subjects within 10 days of supplementation. this study aims to investigate the duration of oral curcumin supplementation needed to see clinical impact in reducing volume and number of drusen and decreasing choriocapillaris density loss or flow impairment in dry amd patients. patients will be given a 12-month course of oral longvida curcumin and clinical impact will be measured by multimodal retinal imaging (fundus photos, oct and oct-a) at day 0, month 3, month 6, and month 12 of supplementation. previous small studies have shown change in drusen size within 4 6months of curcumin supplementation, given that drusen can naturally fluctuate in size, we want to have a longer study period with a control group to better understand the effects of curcumin on drusen characteristics.


Eligibility criteria:
inclusion criteria: * age \> 50 years old bcva 20/20 to 20/400 dry amd with many large (\>300 μm in diameter and more than 100 μm in height) soft drusenoid peds exclusion criteria: * presence (or history) of significant geographic atrophy or choroidal neovascularization in either eye; history of eye surgery (other than cataract extraction) within 90 days, history of brvo/crvo, macular hole, pathologic myopia, uveitis, pseudovitelliform maculopathy will be excluded.
efficacy of ipack block and surgeon's joint infiltration in total knee arthroplasty

Conditions: Osteo Arthritis Knee

Summary: total knee arthroplasty(tka) is an effective modality for the treatment of advanced osteoarthritis of the knee joint with excellent outcomes. with 719,000 cases being performed as of 2010, the incidence is expected to increase up to 3.48 million procedures annually by 2030.

there have been several studies regarding efficacy of peri articular infiltration. ipack block is a novel technique gaining popularity where one injects local anesthesia safely under ultrasound guidance in the interspace between the popliteal artery and capsule of the knee. there have been no studies till date comparing the efficacy between ipack block and periarticular infiltration (pai).

Eligibility criteria:
inclusion criteria: * asa (american society of anesthesiology) class i-iv * age 18-75. exclusion criteria: * asa class v * morbid obesity * patient refusal * patients with chronic pain or on pain medication * allergy to la * patients receiving any additional regional techniques * coagulopathy * patients receiving systemic anticoagulation * local infection and procedures anticipated to last more than 5 hours.

Keywords: total knee arthroplasty peri articular infiltration pack block adductor canal catheter
intravenous branched chain amino acids for hepatic encephalopathy in aclf

Conditions: Hepatic Encephalopathy; Acute-On-Chronic Liver Failure

Summary: this study analyses the effect of intravenous branched chain amino acids (bcaa) on overt he in patients with aclf. the investigators plan to study the efficacy of combining intravenous bcaa with lactulose versus lactulose alone in the medical management of overt he in patients with aclf and its impact on overall survival and improvement in grade of he.

acute on chronic liver failure (aclf) is a distinct clinical entity in the spectrum of chronic liver disease associated with high short term mortality. hepatic encephalopathy (he) is commonly seen in patients with aclf and its treatment mainly involves non-absorbable disaccharides (lactulose/lactitol).treatment of he in aclf is based on extrapolation of data available from cirrhotic patients. no studies have compared different treatment options for he in patients with aclf.

Eligibility criteria:
inclusion criteria: 1. age 18-75 years 2. either gender 3. patients with aclf (canonic definition) of any aetiology with he ≥grade 2 as per west-haven criteria or hepatic encephalopathy scoring algorithm (hesa) exclusion criteria: 1. those who do not consent to participate in the study 2. patients with structural brain lesions or stroke 3. inability to obtain informed consent from patient or relatives 4. severe preexisting cardiopulmonary disease 5. renal dysfunction (s. creatinine ≥ 2mg/dl) 6. pregnancy/lactation 7. post liver transplant patients 8. hiv infection 9. patients who are on psychoactive drugs, like sedatives or antidepressants 10. patients who are too sick to carry out the protocol as the study was carried out during the peak of the covid-19, patients who developed covid-19 after randomization were excluded from the analysis as they were shifted to dedicated covid-19 icu's.

Keywords: branched chain amino acids hepatic encephalopathy lactulose acute on chronic liver failure bispectral index
epidural dexamethasone versus betamethasone for treatment of lumbosacral radiculalgia

Conditions: Chronic Pain

Summary: this study evaluate the administration of epidural betamethasone versus dexamethasone for pain reduction, consumption of analgesic and quality of life. half of the patient will receive dexametasone and the other half betametasone.


Eligibility criteria:
inclusion criteria: * unilateral leg pain secondary to lateral stenosis, disc protrusion or herniated disc. * age between 18 and 80 years. * moderate to severe pain (nvs\>4). * right proficient oral and written language. exclusion criteria: * patients with high intracranial pressure. * patients with multiple sclerosis. * patients with guillain-barré syndrome radiculopathy of vascular origin. * patients with previous lumbar surgery. * patients pregnant or lactating. * patients with allergy or intolerance to any of the drugs used. * patients with severe cognitive impairment. * patients with intrathecal injectio radiculalgia. * patients with poorly controlled major psychiatric pathology. * patients with type i diabetes or poorly controlled type ii diabetes (hb1ac\>8.5). * patients with glaucoma. * patients with caudal equine syndrome. * patients with pre-treatment with steroid injections/or local anesthetics. * patients with central canal stenosis. * patients with chronic treatment with oral corticosteroids without stabilized pattern.

Keywords: radiculalgia chronic pain quality of life